ELA026 treatment for secondary hemophagocytic lymphohistiocytosis (sHLH).

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study enrolls pediatric and adult participants with newly diagnosed or relapsed/refractory secondary HLH who meet HLH-2004 criteria. Part 1 used dose-escalation and fixed-dose cohorts to evaluate safety, pharmacokinetics, and pharmacodynamics of intravenous and subcutaneous ELA026 and to select a Phase 3 dose and schedule. Part 2 (SURPASS) is an open-label, single-arm, multicenter registrational study using historical controls to test efficacy in treatment‑naïve adult and pediatric cohorts, including malignancy-associated and other triggers. Participants receive ELA026 over a defined treatment period with regular clinical and laboratory monitoring for response and safety.

Why it matters

Who can join: the full rules

Key Inclusion Criteria for Part 1:

1. ≥12 years at the time of HLH diagnosis (Cohort 1).
2. ≥6 years at the time of HLH diagnosis (Cohort 2-3).
3. Treatment naïve or relapsed/refractory (Cohorts 1 and 2).
4. Treatment naïve or early refractory (Cohort 3).
5. Participant with sHLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria.

Key Inclusion Criteria for Part 2:

1. Cohort A: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH.
2. Cohort B: Adults with newly diagnosed, treatment-naïve, non-malignancy-associated sHLH.
3. Cohort B: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH, diagnosed by OHI index.
4. Cohort B: 13 to 17 years olds with newly diagnosed, treatment-naïve sHLH.
5. Cohort B: 6 to 12 year olds, with refractory sHLH (safety lead-in cohort).
6. Cohort B: 6 to 12 year olds, with newly diagnosed, treatment-naïve sHLH (after completion of safety lead-in cohort).

Key Exclusion Criteria for Part 1:

1. Known or previous treatment for primary HLH
2. Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study
3. Unknown trigger for sHLH
4. Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
5. Allogeneic hemopoietic stem cell transplant (HSCT) within 100 days of the first dose of ELA026.
6. Ongoing administration of any therapies used to treat HLH (excluding dexamethasone)
7. Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening

Key Exclusion Criteria for Part 2:

1. Refractory sHLH (except for the safety lead-in cohort for 6-12 year olds in Cohort B).
2. Known or suspected primary or hereditary HLH.
3. Severe organ dysfunction.
4. Any other significant concurrent, uncontrolled medical condition that contraindicates participation in this study or prohibits completion of study procedures.
5. End-stage malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH.
6. Allogeneic hemopoietic stem cell transplant within 30 days prior to enrollment.

Where it's running

• University of Alabama at Birmingham School of Medicine
  Birmingham, Alabama, United States Recruiting
• MedStar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Johns Hopkins All Children's Hospital
  St. Petersburg, Florida, United States Recruiting
• Children's Healthcare of Atlanta - Center for Advanced Pediatrics
  Atlanta, Georgia, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• National Institute of Allergy and Infectious Diseases (NIAID)
  Rockville, Maryland, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials
• Email: clinicaltrials@electra-therapeutics.com
• Phone: Please email

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluation of secondary hemophagocytic lymphohistiocytosis and its immune mechanisms

  This study is trying to understand the immune system's role in secondary hemophagocytic lymphohistiocytosis by looking closely at patients' health and blood over a year to find better treatment options.

  Recruiting at 2 sites National Institutes of Health Clinical Center (CC) · Bethesda, Maryland and 1 other locations · NCT06339177

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.